Two major studies published on Saturday provide evidence that drugs derived from fish oil are effective in protecting people from fatal heart attacks, stroke and other forms of cardiovascular disease.
Large, multi-annual research efforts have tested various formulations and amounts of Omega-3 fatty acids in two groups of people: those who have suffered from cardiovascular disease or diabetes, and others who represent the general population. Both studies have shown that people taking the medication every day enjoyed protection against some cardiac and circulatory problems compared to those who received placebo.
By looking at another, usually consumed vitamin D supplement, the researchers found no effect on heart disease, but over time they saw association with cancer deaths.
The study was published on Saturday at the American Medical Association's 2018 Scientific Sessions in Chicago and published in the New England Journal of Medicine.
Approximately 43 million people in the United States take statins for lowering LDL or "bad" cholesterol, and medications are attributed to reducing the risk of heart attacks and stroke. But heart disease remains the leading killer of Americans. In recent years, the long, steady reduction in deaths of heart disease has slowed down. Scientists are still looking for ways to fight cardiovascular disease beyond well-known protective factors such as diet, exercise, and smoking habits.
One of the studies discovered on Saturday, called REDUCE-IT, found that people with cardiovascular disease who had already taken statins had less chance of serious heart problems when two drops of Vascepa (icosapent ethyl) twice a day were given twice a day.
The medicine is a cleansed version of the fish oil component that targets triglycerides, another type of fat in the blood. Increased triglycerides can harden or thicken the arteries, which can lead to stroke and heart attacks. People who took the medicine were compared with those who received placebo. The survey encompassed more than 8,000 people.
The drug was made by Amarin Corp., which sponsored the research. In September, Amarin announced that the study had met its primary goals.
Deepak L. Bhatt, executive director of the Interventional Cardiovascular Program at Brigham and the Women's Hospital in Boston, who led the study, said results could change cardiology practice the same way as introducing statin more than 30 years ago.
"Honestly, I've been doing clinical trials for a long time, and I was not involved in a trial that has so much potential for tens of millions of lives to improve," Bhatt said.
In 2007, a large study in Japan found that the same components of fish oil used in REDUCE-IT studies showed promising protection against cardiovascular problems. But this study did not compare the substance with the placebo and complicated the large amount of fish in a typical Japanese diet.
Another study of fish oil published on Saturday, called VITAL, observed the effect of a variety of Omega-3 fatty acid formulations in the drug Lovaza. Researchers have tracked nearly 26,000 people for a median of more than five years. The results suggest that people who took drugs 28% less likely to suffer from heart attacks than those with placebo and 8% less likely to have different cardiovascular events. The impact was even more pronounced among African Americans, but the main researcher says the results should be further studied before they can rely.
People who ate less than 1.5 meals a week saw a drop in the number of heart attacks that they suffered when they increased consumption of Omega-3s by taking the drug. The study did not find a stroke.
JoAnne Manson, the head of the Preventive Medicine Division at Brigham and the Women's Hospital, who led the study, said she "continues to support the benefits of Omega-3 in heart health."
Manson has called for "promising signals" about the consumption of fish oil but say they are not convincing enough to force people to start taking drugs or fish oil supplements. The study also showed that the drug is sufficiently certain that people who already have fish oil have no reason to stop, she said in an interview.
People in the research are given 840 milligrams of key fatty acids in fish oil each day, less than they are in typical salmon serving.
"We would be encouraged to start with more fish in the diet and at least two meals a week," Manson said. "One advantage it is through nutrition.,, Is that fish can replace red meat, saturated fat and processed food."
Lovaza produces GSK, but is available in generic form. The research is under the auspices of the National Institutes of Health.
The VITAL study also looked at vitamin D, which is often recommended for improving bone health in older women and for general health in other people. He found that vitamin had no effect on heart attacks or stroke and did not affect the incidence of cancer.
But vitamin D consumption may play a role in reducing the number of cancer deaths two or more years later, research has shown. Manson suggested that vitamin D can help prevent metastasis or invasive cancer. But she said the idea needed more research.
She said that people are already taking modest amounts of vitamin D, especially at the advice of doctors, there is no reason to stop. But she warned against taking large doses of vitamins, such as 5,000 or 10,000 international units a day unless the clinician recommends it because the safety of such practices is unknown.